ABSTRACT
Background: Benefit of early awake prone positioning (PP) for COVID-19 patients hospitalised in medical wards and who need oxygen therapy remains to be demonstrated. The question was considered at the time of COVID-19 pandemic to avoid overloading the intensive care units. We aimed to determine whether PP plus usual care could reduce the rate of non-invasive ventilation (NIV) or intubation or death as compared with usual care alone. Methods: In this multicentre randomised clinical trial, 268 patients were randomly assigned to awake PP plus usual care (N=135) or usual care alone (N=132). The primary outcome was the proportion of patients who underwent NIV or intubation or died within 28 days. Mains secondary outcomes included the rates of NIV, of intubation or death, within 28 days. Results: The proportion of NIV or intubation or death within 28 days was 14.1% (19/135) in the PP group and 12.9% (17/132) in the usual care group (odds ratio adjusted for stratification [aOR] 0.43; 95% confidence interval [CI] 0.14 to 1.35). The probability of intubation, or intubation or death (secondary outcomes) was reduced in the PP versus usual care group (aOR 0.11; 95%CI 0.01 to 0.89 and aOR 0.09; 95%CI 0.01 to 0.76, respectively) in the whole study population and in the prespecified subgroup of patients with SpO2 ≥95% on inclusion (aOR 0.11; 95%CI 0.01 to 0.90, and aOR 0.09; 95%CI 0.03 to 0.27, respectively). Conclusions: Awake PP plus usual care in COVID-19 patients in medical wards did not decrease the need for NIV or intubation or death. Trial registration: ClinicalTrials.gov Identifier: NCT04363463. Registered 27 April 2020.